Safety and Effectiveness Evaluation of Spinal Laminectomy Robot

Recruiting now · Not applicable

Conditions studied: Lumbar Spinal Stenosis, Lumbar Disc Herniation

In brief

The purpose of this clinical trial is to evaluate the effectiveness and safety of this spinal robot in assisting doctors to perform laminectomy in spinal surgery under the premise of ensuring the safety of the subjects and ensuring the scientific nature of the clinical trial.

Key facts

Study ID

NCT06593574

Run by

Peking University Third Hospital

People needed

70

Starts

2024-10-15

Expected to finish

2025-12-30

Last updated by the study team

2024-10-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged 18-80 years old (including 18 and 80 years old), regardless of gender;
• Patients with complete clinical data, willing and able to sign informed consent;
• Patients with lumbar disc herniation, lumbar spinal stenosis, lumbar instability, lumbar spondylolisthesis, and lumbar fracture meet the indications for spinal laminectomy and undergoing open surgery；
• Patients with lumbar disc herniation, lumbar spinal stenosis, or lumbar instability have one of the following:
• It was not effective after 3 months of conservative treatment
• Symptoms seriously affect the quality of life
• cauda equina nerve injury
• Lumbar spondylolisthesis occurs in one of the following:
• Symptoms of II° and below slip were not relieved by non-surgical treatment
• Lumbar spondylolisthesis III° and above
• Symptoms of lumbar spinal stenosis
• The TLISS score of lumbar spine fracture is greater than or equal to 4 points.

You may not qualify if…

• Patients who are not suitable for robot-assisted surgery;
• Patients with existing implants in or near the vertebral body of the lesion;
• Patients whose vertebral lamina bone tissue of the focal vertebra or adjacent vertebra has been removed;
• Pregnant and lactating female patients;
• the subject is unwilling or unable to restrict activities or follow medical advice;
• Patients with infection near the focal area;
• The patient is mentally incapable or unable to understand the requirements for participating in the study;
• The patient is critically ill, the expected survival period is not more than 2 years, and it is difficult to make an accurate assessment of the effectiveness and safety of the device;
• Patients with coagulation dysfunction;
• Other researchers did not consider it suitable for admission.

Where it is running

• Peking University Third Hospital — Beijing, China (enrolling)
• Third Affiliated hospital of Southern medical university — Guangzhou, China
• Zhejiang Provincial Hospital of Chinese Medicine — Hangzhou, China

Full record on ClinicalTrials.gov

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